Phase 4
N=500
Patient-Reported Effectiveness and Safety of Etoricoxib in Osteoarthritis (OA)(0663-113)
Pain
Bottom Line
View on ClinicalTrials.gov: NCT00757627 ↗Enrolled (actual)
500
Serious AEs
1.2%
Results posted
May 2010
Primary outcome: Primary: The Percentage of Participants Achieving ≥30% Decrease From Baseline in Pain Intensity as Measured by WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) Question 1 "Pain Walking on a Flat Surface" at Week 4 — 52.04 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- etoricoxib (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Organon and Co
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage of Participants Achieving ≥30% Decrease From Baseline in Pain Intensity as Measured by WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) Question 1 "Pain Walking on a Flat Surface" at Week 4 |
52.04 | — |
| SECONDARY Mean Change From Baseline in Patient WOMAC Domain Scores at Week 4 |
-10.0; -7.9; -8.0 | — |
| SECONDARY Physicians' Global Assessment of Patients' Response to Therapy at Baseline Using IGART (Investigator Global Assessment of Response to Therapy) |
4.40; 57.60; 36.40; 1.60; 0.00 | — |
| SECONDARY Physicians' Global Assessment of Patients' Response to Therapy at Week 4 Using IGART |
5.81; 16.05; 35.35; 36.74; 6.05 | — |
| SECONDARY Patient Assessment of General Health Outcome by EuroQoL-5 Dimensions (EQ-5D) at Baseline |
54.91; 45.09; 0.00; 86.97; 12.63; 0.40 | — |
| SECONDARY Patient Assessment of General Health Outcome by EuroQoL-5 Dimensions (EQ-5D) at Week 4 |
67.61; 32.39; 0.00; 90.05; 9.48; 0.47 | — |
| SECONDARY Change From Baseline of Patient BPI (Brief Pain Inventory) Scores at Week 4 |
-1.5; -0.6; -1.0; -1.3; -0.8; -1.0 | — |
| SECONDARY Changes From Baseline in Patient TSQM (Treatment Satisfaction Questionnaire for Medication) Domain Scores at Week 4 |
2.8; -3.8; 0.9; 1.1 | — |
| SECONDARY Change From Baseline in Number of Days Patient Miss From Work or House Keeping Work at Week 4 |
-0.4; -2.3 | — |
| SECONDARY Change From Baseline in Patient-SF36 (Short Form 36) Domain Scores at Week 4 |
5.2; 17.6; 10.6; 2.0; 1.4; 8.7 | — |
Summary
The purpose of this study is to collect disease burden of OA and the effectiveness and patient satisfaction of treatment by Etoricoxib in the normal practice setting.
Eligibility Criteria
Inclusion Criteria
- Must Be Over 20 Years Of Age, Regardless Of Sex
- Must Have A Diagnosis Of OA That Requiring Treatment
- Patients Must Have Taken an NSAID, Cox-2 Or Opioids On The Majority Of Days During The Last 4 Weeks Before Enrollment Who Are Intolerant (Due To Gastrointestinal Adverse Events) Or Inadequately Respond To Current Therapy (Vas >= 40 mm On A Pain Scale From 0-100 mm)
- Excluding Osteoarthritis, The Patient Is Judged To Be In Otherwise General Good Health Based On Medical History, Physical Examination, And Routine Laboratory Tests
- Must Agree To Participate Voluntarily In The Study
- Must Have The Capacity To Understand And Answer The Questionnaires Used In The Study
- Must Agree To Return For A Follow-Up Visit With The Treating Physician Four Weeks After The Initiation Of Treatment With Etoricoxib
- Patient Is Willing To Sign Informed Consent Form
Exclusion Criteria
- Under 20 Years Of Age
- Severe Hepatic Insufficiency (Child-Pugh Score > 9)
- Advanced Renal Insufficiency (Creatinine Clearance < 30 Ml/Min)
- Any Contraindication Or Warning Or Precaution As Mentioned In The Approved Study Drug Package Insert
- Gi Ulcer With Active Bleeding Present At Study Enrollment
- Patient Has A Recent History Of Stroke, Myocardial Infarction Or Transient Ischemic Attack (Within The Previous 2 Years)
Data sourced from ClinicalTrials.gov (NCT00757627). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.